- By Deb Balzer
Mayo Expert: FDA Orders Reclassification of Transvaginal Mesh Devices
The U.S. Food and Drug Administration (FDA) has ordered manufacturers of surgical mesh devices used for transvaginal repair of pelvic organ prolapse (POP) to address serious safety concerns. The FDA will now require manufacturers to reclassify the medical devices from moderate-risk devices to high-risk devices, as well as order manufacturers to submit a premarket approval of surgical mesh for the transvaginal repair of POP. Mayo Clinic obstetrician-gynecologist Dr. John Gebhart says tens of thousands of patients have been adversely affected by the devices. He says the FDA order has brought to the forefront issues associated with the safety and efficacy of transvaginal placement of mesh for prolapse.
Dr. Gebhart also says there is a common misconception that slings used to treat urinary incontinence are unsafe. "The use of slings for stress incontinence are not a part of the FDA warning but because they are mesh, there is some confusion. If properly performed slings for urinary incontinence are safe procedures and should not be products that are used for prolapse transvaginally and it's an important distinction."
Common problems associated with transvaginal mesh devices include severe pelvic pain, bleeding, exposure of the material, pain with intercourse and urinary problems.
If you've had a procedure done and have questions, Dr. Gebhart says the first step is to to see your provider.
Journalists: Broadcast quality sound bites are available in the downloads.